Brainsway’s Deep TMS “a beacon of hope” for depression patients

Brainsway (TASE:BRIN) plans to submit an application by the end of the second quarter this year to the FDA for marketing approval of its deep transcranial magnetic stimulation (Deep TMS) with its H-Coil device in the treatment of major depression after reporting “excellent results” in a multicenter pivotal trial.

At the end of five weeks of treatment, considerably lower levels of depression were recorded, with a clinically and statistically significant difference between the real treatment group and the sham control group. A large majority of patients tolerated the treatment well, with no side effects.

The company said 30.4% of patients in the treatment group achieved remission from depression as defined by the Hamilton Depression Rating Scale (HDRS-21), compared with 14.5% in the control group (p=0.0148).

Significant response to treatment was experienced by 36.7% of patients in the treatment group, compared with 20.5% in the control group, also a statistically significant difference.

A statistically significant difference of three points on the HDRS was found between the treatment group and the control group at the conclusion of five weeks of treatment, Brainsway added.

The company also said a preliminary analysis of the results from 16 weeks of treatment indicates a “significant difference in the response to treatment between the treatment and control groups.” The full results will be available after a statistical analysis has been performed.

Brainsway's Deep TMS System

“This is a very exciting day for Brainsway,” CEO Uzi Sofer said in a statement. “We are gratified to see all our hard work rewarded by such excellent results.”

Prof. Hilik Levkovitz, director of the day care unit and the Emotion and Cognition Research Center at the Shalvata Mental Health Hospital, said the clinical trial “shows us that the deep TMS device is safe and effective for the treatment of major depression. The proof of the safety and efficacy of the device is nothing less than a breakthrough, a beacon of hope for psychiatric patients.”

Prof. Abraham Zangen of the University of Ben-Gurion, one of the inventors of the deep TMS technology and Brainsway’s scientific consultant said the rates of response and remission are very high considering the target population of patients who failed to respond to previous treatment with medications. “There is no doubt that the device we’ve developed can help a lot of patients,” he added.